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What is a Strategic Medical Writing Partnership? And Should I Set One Up?

March 31, 2016 | Tim Garver, PhD, Executive VP and Chief Operating Officer | Medical Writing Services

There are a myriad of terms that refer to the different types of long-term contractual relationships that can exist between Sponsors (including large and small pharma or biotech companies) and service providers (whether they be CROs [large or small] or independent contractors).

IMPACT has been engaged in a variety of different types of arrangements with our clients over the years, but there is one relationship in particular that I want to talk about here: a Strategic Medical Writing Partnership between a Sponsor and a CRO (namely, us).

What is a strategic medical writing partnership, you ask? Let me help explain.

Types of Long-term Contract Models

In order to understand what a strategic medical writing partnership is, it’s helpful to have a background on other long-term outsourcing options that are potentially available.

For example, with many clients we have a “Master Services Agreement” (ie, an MSA) in place that houses all of the legal mumbo‑jumbo, which is nice since reviewing contractual language at the outset of each new project with the same client isn’t necessary. Many times, MSAs don’t include details on agreed-upon pricing for the services we can offer and, thus, these prices must be negotiated prior to the initiation of any project, and specified in a Task Order to the MSA.

For some clients, we are considered a “Preferred Provider” – which may or may not lead to “guaranteed” work – but results in both agreed-upon contractual language AND pricing. Therefore, when there is work to be done, we can get started right away.

The other type of long-term option we can provide is a “Strategic Medical Writing Partnership” – which is contractually similar to a Preferred Provider relationship – but is established with the intention of creating a true partnership between companies; that is, a Sponsor earmarking certain type(s) of deliverables for us.

What is a Strategic Medical Writing Partnership?

While the term “strategic partnership” may bring up visions of the “soup-to-nuts” services that large CROs can provide for clinical trial work (ie, study management and conduct, data management, biostatistics), that’s not what it means in our case.

Because we specialize in medical writing (as well as regulatory affairs and regulatory operations), we only offer (and partner) for these particular services. Companies like ours are sometimes referred to as “niche CROs”, and when niche CROs establish a strategic partnership with a client, it’s for a service offering that’s in their wheelhouse (sometimes you’ll hear this called a “functional service provider”).

partners

Over the past few years we have been engaged in a successful strategic partnership that covers medical writing and report-level electronic publishing of CSRs, services that we pride ourselves on!

In an upcoming blog post we’ll talk about the nuts and bolts of what’s required in setting up a successful strategic medical writing partnership. We’ll cover topics such as contract negotiations, fixed-pricing agreements, training, governance councils, etc. For now, though, let’s focus on why you might want to set one up and the benefits a partnership can potentially provide.

What are the Advantages to the Sponsor?

When a successful strategic medical writing partnership is formed and executed, what are some of the potential advantages a Sponsor can expect? Remember, these are from our CRO perspective.

  • Mutual Trust: A successful partnership requires honesty and transparency in both directions regarding resourcing, issue escalation, and training, among other things. When a trusted partnership is established, downstream success on all work products ensues.
  • Alignment in Work Philosophies: Partnering helps ensure that CRO team members work in a manner similar to the Sponsor’s internal team and that the CRO’s writers integrate seamlessly into the Sponsor’s project teams. Aligned work philosophies are crucial to partnership success.
  • Commitment to Overall Sponsor Success: Over time, familiarity with the Sponsor’s projects, products, and team members result in the CRO writers becoming even more committed to and invested in the Sponsor’s overall success. It’s more than just meeting expectations on a single project – long-term partnerships provide the opportunity for CRO personnel to help the Sponsor meet their overall corporate goals.
  • Increased Agility: Due to streamlined (or absent) contract and price negotiations, strategic partnerships allow for increased agility on the CRO’s side– when last minute needs arise for the Sponsor, the CRO can be there quickly to meet their demands.

And, finally……

  • Becoming an Extension of their Team: The highest-quality documents are ensured when dedicated CRO personnel are trained on how to work within the Sponsor’s teams, processes, and systems. When this happens, CRO writers become an extension of the Sponsor’s project teams and produce documents that match the level of what is expected from their internal team.

Taken all together, a successful strategic partnership helps reduce the (many) stresses associated with day-to-day outsourcing that can come from working with multiple vendors who provide varying levels of consistency, quality, commitment, and/or competency. Simultaneously, medical writing partnerships result in high quality documents being written by CRO writers who have become as familiar with, and committed to, the Sponsor’s products, programs, and overall company goals as their internal writers.

What are the Advantages to the CRO?

Simply stated, all of the advantages of a strategic partnership from the Sponsor perspective are also advantages from the CRO’s perspective.

While the most obvious advantage for the CRO specifically is the reliable workflow that may be provided by a strategic medical writing partnership, there is more to it than that.

Working with a Sponsor who is aligned with your writing philosophy is critical for keeping the CRO engaged and satisfied with their work….and allows the CRO to truly function as an extension of the Sponsor’s team.

And when CRO medical writers become trusted members of the Sponsor’s project team, they are given the ability to do what they love to do…be clinical research scientists and help bring new compounds to market!

team

In addition, while the front-loading of contract and price negotiations benefits the Sponsor, it also greatly benefits the CRO. Not only does this minimize the amount of “non-billable” work that needs to be devoted to “landing the project,” but when pricing and work requirements are known, the CRO has an important piece of their revenue projection puzzle in place….which helps to drive other business development activities and hiring plans.

Let us know what you think

That’s enough from us. What do you think about strategic medical writing partnerships? Have you ever established one, or think you might want to establish one? If so, please don’t hesitate to contact us, or better yet, come talk to us at the DIA annual meeting in Philadelphia on June 30th, 2016 where I will be co-presenting on this topic. We look forward to hearing from you or seeing you there!

Partners and teamwork image courtesy of Stuart Miles and Suriya Kankliang, respectively, from FreeDigitalPhotos.net.

Category: Medical Writing Services
Keywords: strategic medical writing partnership, strategic partnership, regulatory medical writing

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